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Clinical Trials/NCT05138471
NCT05138471
Completed
Not Applicable

Addition of Transcranial Direct Current Stimulation and Transcutaneous Electrical Nerve Stimulation to an Education and Exercise Program in Subjects With Chronic Pain Due to Knee Osteoarthritis.

Universidad de Murcia1 site in 1 country65 target enrollmentNovember 17, 2021

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Osteo Arthritis Knee
Sponsor
Universidad de Murcia
Enrollment
65
Locations
1
Primary Endpoint
Chronic Knee Pain
Status
Completed
Last Updated
last year

Overview

Brief Summary

Knee osteoarthritis has a very high prevalence in the population over 50 years of age. Patients with osteoarthritis often suffer from chronic pain that becomes disabling, affecting both quality of life and mental and physical health. This pathology has also been linked to maladaptive plasticity in the brain, which can contribute to chronic pain. Therapies with neuromodulatory approaches, such as transcranial direct current stimulation (tDCS) and peripheral electrical stimulation (TENS), have been used therapeutically to counteract the maladaptive plasticity of the brain.

Transcranial therapy and TENS can be a possible effective treatment in the rehabilitation services of the health system for the improvement of chronic pain and quality of life in different pathologies, such as chronic low back pain, fibromyalgia or knee and hip osteoarthritis.

Registry
clinicaltrials.gov
Start Date
November 17, 2021
End Date
May 1, 2024
Last Updated
last year
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • Adults over fifty years of age with a diagnosis of knee osteoarthritis by radiography.
  • Chronic pain of more than six months, compliance with the diagnostic criteria for knee osteoarthritis according to the Osteoarthritis Research Society International (OARSI) guideline:
  • Pain in Analog Visual Scale more than 4/10
  • Matutinal less than 30 minutes
  • Absence of hyperthermia upon palpation in the joint
  • Alteration of the bone image

Exclusion Criteria

  • Patients who can provide low-quality or biased information discriminated by the Mini-Mental State Examination (Score less than 24).
  • Severe hearing, visual or sensory impairment or comorbidities that prevent the correct completion of the questionnaires and mobility activities.
  • Patients who have undergone knee replacement surgery on the contralateral knee.
  • Patients who have received intervention (infiltration, blockages, etc...) in the last 6 weeks.
  • Pain due to tendinopathy, knee fracture, low back pain radiating to the knee, or fibromyalgia.
  • Patients who decline to participate out of fear or denial of therapy.
  • Severe heart disease that prevent exercise.
  • Body Mass Index above
  • Patients with neuropsychiatric disorders (schizophrenia, epilepsy or bipolar disorders) or taking medication for these conditions (antiepileptic drugs).
  • Patients with metallic implants in the area (skull or knee).

Outcomes

Primary Outcomes

Chronic Knee Pain

Time Frame: Through study completion, an average of 1 year.

The Visual Analogic Scale will be used to assess the impact on chronic knee pain. The values range from 0 to 10 (0 = No pain, 10 = the worst pain).

Secondary Outcomes

  • Coordination and Balance(Through study completion, an average of 1 year.)
  • Function and Quality of Life(Through study completion, an average of 1 year.)
  • Force(Through study completion, an average of 1 year.)
  • Balance(Through study completion, an average of 1 year.)
  • Gait properties.(Through study completion, an average of 1 year.)
  • Central Sensitization(Through study completion, an average of 1 year.)
  • Kinesiophobia(Through study completion, an average of 1 year.)
  • Uncertainly(Through study completion, an average of 1 year.)
  • Catastrophizing(Through study completion, an average of 1 year.)

Study Sites (1)

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